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Blood filter attached to Heart-Lung machine aims to stop ticagrelor bleeding

NCT ID NCT07822620

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Patients who take ticagrelor and then need heart bypass surgery face a higher risk of serious bleeding because the drug blocks platelets and transfusions cannot reverse it. The TICAdSORB trial tests whether a blood-filtering cartridge called Cytosorb, placed in the heart-lung machine during surgery, can remove ticagrelor from the blood and lower bleeding. Researchers randomly assign 232 adults who took ticagrelor within 48 hours before surgery to receive either the Cytosorb filter or a sham tubing line without the cartridge. The main measure is how many patients have moderate to massive bleeding in the first 48 hours after bypass.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cytosorb hemoadsorption cartridge, a blood-filtering device added to the heart-lung machine
What this could lead to
If it works, this could give surgeons a way to operate sooner on patients who took ticagrelor, without waiting days for the drug to clear and risking another heart event.
What could go wrong
The trial may show the filter does not reduce bleeding enough to matter, or that it removes other blood components with unwanted effects. Results in this specific surgery setting may not apply to other operations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 232 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient or patient's representative having read and understood the information letter and signed the consent form 2. Age ≥ 18 y/o 3. Ticagrelor administration within 48 hours prior to surgery 4. Cardiac surgery with cardiac bypass 5. Patient affiliated with, or beneficiary of a social security (health insurance) category. 6. Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile): 1. with effective contraception (Cf. CTCG) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during study period 2. negative blood pregnancy test by b-HCG at inclusion. 7. Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) 8. Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Exclusion Criteria: 1. Concomitant antiplatelet drugs or ongoing anticoagulants other than aspirin and heparin 2. Ongoing systemic infection (including active endocarditis) 3. Ongoing treatment with an antibiotic or antifungal at high risk of removal by Cytosorb®: teicoplanin, vancomycin, linezolid, gentamycin, amphotericin B liposomal, azole drugs or fluconazole 4. Ongoing treatment with an anticonvulsant at high risk of removal by Cytosorb®: phenytoin, phenobarbital or valproic acid. 5. Contraindications to Cytosorb® (known preoperative platelet count \< 20 000/mm3, Sickle cell disease crisis, history to heparin-induced thrombopenia, body mass index ≥ 40 kg/m², hypersensitivity to a component, Any pre-existing contraindication to extracorporeal therapy (CPB)) 6. Cardiac surgery for ventricle assistance device or transplantation 7. Preoperative critical state 8. Chronic pathology with life expectancy less than 1 month 9. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception 10. Absence of affiliation to a social security program 11. Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision 12. Person consenting to the research participating having participated to another trial within a period of one week 13. Person participating to another interventional research

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As listed by the trial registrant

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Contacts and locations

Locations

  • CHU de Rouen

    Rouen, France

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